510(k) K883260
K883260 is an FDA 510(k) premarket notification submitted by Dittmar and Penn Corp. for the device "DITTMAR POWER LIFTER". The FDA issued a decision of Substantially Equivalent on November 7, 1988. The device falls under product code FOX (Stand, Infusion), a Class I device regulated under 21 CFR 880.6990. Dittmar and Penn Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 7, 1988
- Date Received
- August 3, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stand, Infusion
- Device Class
- Class I
- Regulation Number
- 880.6990
- Review Panel
- HO
- Submission Type